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The Perfix™ Spinal System is a posterior, noncervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion by autogenous bone graft in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar and sacral spine:

• Spondylolisthesis (Grade 3 and 4) .
• Degenerative spondylolisthesis with objective evidence of neurological impairment
• Trauma (i.e., fracture or dislocation)
• Spinal stenosis .
• Spinal deformities (Scoliosis, Kyphosis, Lordosis) .
• Pelvic obliquity ●
• Spinal tumor
• Pseudarthrosis
• Failed previous fusion

The Perfix™ Iliac Screw System includes the following four components; iliac screw, iliac connector, iliac cap, and a set screw. These components are only to be used in conjunction with the Perfix™ Spinal System's 6.0mm diameter rods.

Perfix™ Iliac Screw System consists of a variety of shapes and size of iliac screws, iliac connectors, iliac screw cap and set screw. All implant components are made from a titanium alloy (Ti-6Al-4V ELI) in accordance with ASTM F136. Perfix" Iliac Screw System is intended to provide spinal stability related to the lumbosacral fixation or spinopelvic fixation is provided by iliac screws inserted into the vertebral body of the lumbar spine and sacrum regions using a posterior approach.

The U&I Corporation's Perfix™ Iliac Screw System underwent non-clinical (bench) testing to demonstrate its performance and establish substantial equivalence to predicate devices. The study aimed to show that the device met established acceptance criteria, indicating no new safety or efficiency issues compared to existing, legally marketed spinal fixation systems.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document states that the mechanical performance of the Perfix™ Iliac Screw System met the acceptance criteria which have been established from the predicate devices. However, the exact numerical acceptance criteria for each test and the specific reported performance values for the Perfix™ system are not detailed in the provided text. The document generally confirms that the tests were performed and the device met the criteria.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify the exact number of devices or constructs tested for the "test set" in the performance testing.
• Data Provenance: The study was a non-clinical setting (bench testing). Data provenance is not geographical in this context, but rather refers to the type of experimental setup. It is retrospective in the sense that the acceptance criteria were established from existing predicate devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This question is not applicable to this study. The "ground truth" for this type of mechanical performance testing is defined by established engineering standards (ASTM F1717) and the performance of predicate devices, not by expert medical opinion on individual cases.

4. Adjudication Method for the Test Set

This question is not applicable to this study. Adjudication methods are typically used in clinical studies involving interpretation of medical data by multiple observers. This study involved mechanical testing against predefined criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study focused on the mechanical performance of a medical device, not on the interpretative performance of human readers, with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

N/A. This device is a physical spinal implant system, not a software algorithm. Therefore, "standalone" algorithm performance is not relevant. The performance testing was for the physical device itself.

7. The Type of Ground Truth Used

The "ground truth" for the performance testing was based on:

• Established industry standards: Specifically, ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model).
• Performance of predicate devices: The Perfix™ Iliac Screw System was compared directly against the mechanical performance of the Synergy™ Spinal System - Synergy VLS Screws (K011437), OPTIMA™ Spinal System (K024096), and Global Spinal Fixation System™ (K001668). The acceptance criteria were derived from these predicate devices.

8. The Sample Size for the Training Set

This question is not applicable to this study. There is no concept of a "training set" in a mechanical bench testing study for a physical device.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as there was no training set.

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